After reviewing more than 130 comments on the draft guidance from July 2011, the FDA has issued final guidance for medical apps.
The agency will exercise “enforcement discretion,” which means it will not enforce requirements under the Federal Drug & Cosmetic Act, for the majority of mobile apps.
Instead, the FDA will focus its regulatory oversight on a subset of apps that present a greater potential risk to patients. These types of apps include:
- apps that are intended to be used as an accessory to a regulated medical device
- apps that transform a mobile platform into a regulated medical device
Mobile apps have the potential to transform health care by allowing physicians to diagnose patients with potentially life-threatening conditions outside of traditional healthcare settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it.
Mobile medical apps currently on the market can, for example, diagnose abnormal heart rhythms, transform smart phones into a mobile ultrasound device, or function as the “central command” for a glucose meter used by a person with insulin-dependent diabetes.
“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation,” says Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
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